Posted on Wednesday, 30/Sep/2020 Posted by michelle

Approval of Alkindi® Sprinkle as a replacement therapy of adrenocortical insufficiency in infants, children and adolescents

Market launch anticipated in Q4 2020

>$100m US market potential

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that the US Food and Drug Administration (FDA) has approved Alkindi® Sprinkle (hydrocortisone oral granules) as replacement therapy in paediatric patients with adrenocortical insufficiency (AI).

This approval is based on a positive review of data from the Company’s comprehensive development programme for Alkindi® Sprinkle, including a study to demonstrate bioequivalence with the US reference product, as well as a safety evaluation and tolerability extension study in Europe, which provides valuable long-term exposure data in support of market access in the US.

Alkindi® Sprinkle is a patented, oral, immediate-release formulation of hydrocortisone granules in capsules designed for children. Alkindi® Sprinkle comes in dose strengths consistent with age-appropriate dosing in children. This therapeutic approach has the potential to help patients less than seventeen years of age suffering from diseases due to cortisol deficiency in the US.

Diurnal has partnered with Eton Pharmaceuticals for the commercialisation activities of Alkindi® Sprinkle in the US, including pricing and reimbursement. Eton will initially use product from Diurnal’s European Alkindi® supply chain, with an option to establish its own supply chain in the US in the future. As previously announced, under the terms of the licensing agreement, Diurnal will receive a $2.5m cash milestone payment upon first commercial sale of Alkindi® Sprinkle in the US following grant of Orphan Drug Status. The Company will also receive a tiered royalty on sales ranging from low double-digits to high teens and is due tiered sales-based milestone payments of up to $45 million in aggregate subject to annual sales thresholds. These payments are in addition to the upfront payment of $5.0m received by Diurnal upon signing the contract with Eton in March this year.

Martin Whitaker, CEO of Diurnal, commented:

“We are delighted to receive US FDA approval for Alkindi®, which builds on the previous approval and successful launch of Alkindi® in Europe and marks our first product to reach the market in the US. Alkindi® Sprinkle becomes the only licensed treatment specifically designed for use in children with adrenocortical insufficiency, where there is a significant unmet patient need. We look forward to the anticipated launch of Alkindi® Sprinkle by our partner, Eton Pharmaceuticals, in Q4 2020 as we continue to drive towards becoming a world-leading specialty endocrinology business.”

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

For further information, please visit www.diurnal.co.uk or contact:

Diurnal Group plc +44 (0)20 3727 1000
Martin Whitaker, Chief Executive Officer 
Richard Bungay, Chief Financial Officer 

Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker) +44 (0) 20 7886 2500
Corporate Finance: Freddy Crossley, Emma Earl
Corporate Broking: James Stearns

FTI Consulting +44 (0)20 3727 1000
Simon Conway 
Victoria Foster Mitchell

Notes to Editors

About Alkindi® Sprinkle (hydrocortisone oral granules)

Alkindi® Sprinkle is a patented, oral, immediate-release paediatric formulation of hydrocortisone granules in capsules. Alkindi® Sprinkle comes in dose strengths consistent with age-appropriate dosing in children. This therapeutic approach has the potential to help young patients less than seventeen years of age suffering from diseases due to cortisol deficiency including paediatric AI and congenital adrenal hyperplasia (CAH) in the US. The European Commission has granted a paediatric use marketing authorisation (PUMA) for Alkindi® as replacement therapy of AI in infants, children and adolescents (from birth to <18 years old) in Europe. Alkindi® is also approved in Israel and Australia.

About Paediatric Adrenocortical Insufficiency

Paediatric AI, including the genetic condition CAH is a condition characterised by deficiency in cortisol, an essential hormone in regulating metabolism and the response to stress. The primary symptoms of AI are chronic fatigue and patients are at risk of adrenal crisis and death if they do not have adequate cortisol replacement. AI is either primary or secondary, with primary AI resulting from diseases intrinsic to the adrenal gland and secondary AI resulting from pituitary diseases where there is a failure of stimulation of the adrenal by the pituitary of the signalling hormone ACTH (adrenocorticotropic hormone).

About Diurnal Group plc

Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing high quality products for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia and adrenal insufficiency. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena.

For further information about Diurnal, please visit www.diurnal.co.uk  

Date of Preparation: September 2020                 Code: CORP-GB-0081